ACTIVE_NOT_RECRUITING

Post-Approval Study of the TREO Abdominal Stent-Graft System

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Conditions

Abdominal Aortic AneurysmAAATREOEVAR

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to determine the long-term performance of the TREO Abdominal Stent-Graft as a treatment for patients with Infrarenal Abdominal Aortic Aneurysms or Aorto-iliac Aneurysms.

Official Title

Post-Approval Study of the TREO Abdominal Stent-Graft System (P190015) in Patients With Infrarenal Abdominal Aortic and Aorto-iliac Aneurysms

Quick Facts

Study Start:2021-01-20
Study Completion:2027-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04697784

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Willing and able to comply with all study procedures and visits.
  2. * Written informed consent to participate in the study.
  3. * Patient's aneurysm can be treated with the TREO Abdominal Stent-Graft System.
  4. * Adequate data (medical records/imaging studies) available to analyze the primary endpoints for patients enrolled retrospectively.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Principal Investigator

Gretchen Wild
STUDY_DIRECTOR
Terumo Aortic

Study Locations (Sites)

Vascular Surgery Specialists
Phoenix, Arizona, 85006
United States
Pima Heart and Vascular
Tucson, Arizona, 85718
United States
University of California, San Francisco-Fresno
Fresno, California, 93701
United States
University of California, San Diego
La Jolla, California, 92037
United States
VA San Diego
San Diego, California, 92161
United States
University of Colorado Anschutz
Aurora, Colorado, 80045
United States
Yale University
New Haven, Connecticut, 06520
United States
Medstar Washington Hospital Center
Washington, District of Columbia, 20010
United States
Malcom Randall VA Medical Center
Gainesville, Florida, 32608
United States
University of Florida
Gainesville, Florida, 32610
United States
Coastal Vascular and Interventional
Pensacola, Florida, 32504
United States
University of South Florida / Tampa General Hospital
Tampa, Florida, 33606
United States
Piedmont Heart Institute
Atlanta, Georgia, 30309
United States
Northside Hospital
Atlanta, Georgia, 30342
United States
University of Iowa Hospital and Clinic
Iowa City, Iowa, 52242
United States
Tufts Medical Center
Boston, Massachusetts, 02111
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
McLaren Bay Region
Bay City, Michigan, 48708
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
United States
Barnes Jewish Hospital at Washington University
St Louis, Missouri, 63110
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Rutgers Robert Wood Johnson Medical Center
New Brunswick, New Jersey, 08901
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
Lenox Hill Hospital / Northwell Health
New York, New York, 10075
United States
Stony Brook Medical Center
Stony Brook, New York, 11794-8191
United States
SUNY Upstate Medical University
Syracuse, New York, 13210
United States
Mission Health
Asheville, North Carolina, 27607
United States
East Carolina University
Greenville, North Carolina, 27834
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
VA Portland Healthcare System
Portland, Oregon, 97239
United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
United States
Wellmont Cardiology Services
Kingsport, Tennessee, 37660
United States
St. David's Healthcare (Cardiothoracic and Vascular Surgeons)
Austin, Texas, 78756
United States
University of Utah Hospital
Salt Lake City, Utah, 84132
United States
Sentara Heart Hospital
Norfolk, Virginia, 22042
United States
Virginia Commonwealth University
Richmond, Virginia, 23282
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Bolton Medical

  • Gretchen Wild, STUDY_DIRECTOR, Terumo Aortic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-20
Study Completion Date2027-07-31

Study Record Updates

Study Start Date2021-01-20
Study Completion Date2027-07-31

Terms related to this study

Keywords Provided by Researchers

  • AAA
  • Abdominal Aortic Aneurysm
  • TREO
  • EVAR

Additional Relevant MeSH Terms

  • Abdominal Aortic Aneurysm